BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINAL ANESTHESIA KIT

    MDR report key: 2193450 · Received July 13, 2011

    Report

    Report Number
    1036844-2011-00232
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 12, 2011
    Manufacturer
    ARROW INTL., INC.
    Product Code
    BSP
    PMA / PMN Number
    K911260
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE WILL NOT BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE OPERATING ROOM MGR THAT AFTER THE SPINAL CATHETER WAS INSERTED, THE PT CONTINUED TO FEEL PAIN. THERE WAS NO REPORTED PT DEATH OR INJURY. MEDICAL/SURGICAL INTERVENTION WAS NOT REQUIRED. THERE WAS A DELAY/INTERRUPTION IN THERAPY, HOWEVER, THERE WAS NO HARM TO THE PT. THERE WERE NO PT COMPLICATIONS AND THE PT OUTCOME IS LISTED AS "PT RECEIVED GENERAL ANESTHESIA."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPINAL ANESTHESIA KIT ANESTHESIA PRODUCTS BSP ARROW INTL., INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK